Study of Orphenadrine` in the Treatment of Muscle Cramps in Patients With Cirrhosis

Liver Cirrhosis Clinical Trial

Official title:

Randomized Study of Orphenadrine` in the Treatment of Muscle Cramps in Patients With Cirrhosis

Clinical Trial Details — Status: Recruiting

Administrative data

• NCT number: NCT02423395
• Other study ID #: muscle cramps in cirrhotics
• Status: Recruiting
• Phase: Phase 3
• Start date: January 2015
• Est. completion date: December 2028

Study information

• Verified date: June 2019
• Source: Tanta University
• Contact: Sherief M Abd-Elsalam, lecturer
• Phone: 01000058842
• Email: Sherif_tropical[@]yahoo.com
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

Muscle cramps are common in patients with liver disease and associated with significantly diminished quality of life. Patients with cirrhosis often experience muscle cramps with varied frequency and severity. The exact mechanisms by which they occur remain unclear, although a number of pathophysiological events unique to liver disease may contribute. Clinical studies have identified alterations in 3 areas: nerve function, energy metabolism, and plasma volume/electrolytes (1) Orphenadrine is an anticholinergic drug with prominent central nervous system (CNS) and peripheral actions used to treat painful muscle spasms and other similar conditions. The combination of anticholinergic effects and CNS penetration make orphenadrine useful for pain of all etiologies, including from: radiculopathy, muscles, and headaches. [3,4]

Description:

Muscle cramps are common in patients with liver disease and associated with significantly diminished quality of life. Patients with cirrhosis often experience muscle cramps with varied frequency and severity. The exact mechanisms by which they occur remain unclear, although a number of pathophysiological events unique to liver disease may contribute. Clinical studies have identified alterations in 3 areas: nerve function, energy metabolism, and plasma volume/electrolytes [1].

Although a number of mechanisms for cramps in liver disease have been postulated and have been targeted by medical therapies, a clear picture of the causal events has not emerged. Several agents as vitamin E, human albumin, zinc, taurine, eperisone hydrochloride and branched-chain amino acids have shown some benefit in small uncontrolled studies, although large randomized controlled trials are lacking [2].

Orphenadrine is an anticholinergic drug with prominent central nervous system (CNS) and peripheral actions used to treat painful muscle spasms and other similar conditions. The combination of anticholinergic effects and CNS penetration make orphenadrine useful for pain of all etiologies, including from: radiculopathy, muscles, and headaches. [3,4] Orphenadrine is structurally related to diphenhydramine and carries relatively stronger anticholinergic and weaker sedative properties, It is mostly excreted through the kidneys.[5]

Recruitment information / eligibility

• Status: Recruiting
• Enrollment: 100
• Est. completion date: December 2028
• Est. primary completion date: December 2028
• Accepts healthy volunteers: No
• Gender: All
• Age group: N/A and older

Eligibility

Inclusion Criteria:

• Cirrhosis

• Muscle cramps( =3 cramps per week )

Exclusion Criteria:

• • Allergy to orphenadrine

• Renal impairment

• Pregnant and lactating women

• Peripheral vascular disease

• Peripheral neuropathy

• Medications as calcium channel blockers, conjugated estrogens and naproxen. Glaucoma Prostatic enlargement

Related Conditions & MeSH terms

• Fibrosis
• Liver Cirrhosis
• Muscle Cramp
• Muscle Cramps
• Spasm

Intervention

Drug:
• orphenadrine
Orphenadrine in muscle cramps in cirrhotic patients
• Placebo
calcium in muscle cramps in cirrhotic patients

Locations

Country	Name	City	State
Egypt	Tanta university hospital	Tanta

Sponsors (2)

Lead Sponsor	Collaborator
Sherief Abd-Elsalam	Tanta University

Country where clinical trial is conducted

Egypt, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	Frequency of muscle cramps	questionnaire	3 months
Secondary	Quality of life of these patients	questionnaire	3 months